Sleep apnea is a serious condition in which normal, consistent breathing during sleep is interrupted by either the complete cessation of, or significant reduction in, breathing for a few seconds (e.g., at least 10 seconds) or as long as a few minutes. Sleep apnea affects 4-6% of the general adult population and is even more common in persons with cardiovascular disease. Sleep apnea can lead to or exacerbate many serious health conditions, such as hypertension, heart failure, and pulmonary hypertension.
A common treatment used today for obstructive sleep apnea is continuous positive airway pressure (CPAP) which uses a blower to maintain elevated pressure that holds the patient's airway open. The CPAP device connects through a tube to a mask that is sealed over the patient's nose and mouth while sleeping. However, some patients find the therapy to be uncomfortable and noisy
Alternative treatments for obstructive sleep apnea include a variety of mechanical devices intended to maintain a patient's upper airway, which can be unpleasant or ineffective. Another therapy for central sleep apnea is adaptive servo ventilation (ASV), which has similar user experience issues as CPAP because ASV also requires a sealed mask be placed on the patient's face.
Without treatment, sleep apnea patients may wake up repeatedly in the night. These wake-up episodes may occur at various stages of sleep. If breathing is halted for a long period of time or if the airway becomes fully blocked, the patient may wake up suddenly and completely, struggling to breathe. These episodes may be perceived as frightening by the patient, and severely limit sleep quality. In other instances, the patient may become slightly aware of limited breathing and can shift body position, temporarily to lessen the paralyzed state or take a breath without full arousal. In such cases, the patient resumes breathing easily and falls asleep again quickly.
A need remains for a device that could help patients experience the second type of episode, namely it is desirable to provide a device that would allow the patient to resume breathing without disrupting sleep completely, rather than abruptly awakening.
Neurostimulation systems (NS) are devices that generate electrical pulses and deliver the pulses to nerve tissue to treat a variety of disorders, Spinal cord stimulation (SCS) is the most common type of neurostimulation. In SCS, electrical pulses are delivered to nerve tissue in the spine typically for the purpose of chronic pain control. While a precise understanding of the interaction between the applied electrical energy and the nervous tissue is not fully appreciated, it is known that application of an electrical field to spinal nervous tissue can effectively mask certain types of pain transmitted from regions of the body associated with the stimulated nerve tissue. Applying electrical energy to the spinal cord associated with regions of the body afflicted with chronic pain can induce “paresthesia” (a subjective sensation of numbness or tingling) in the afflicted bodily regions. Thereby, paresthesia can effectively mask the transmission of non-acute pain sensations to the brain.
Neurostimulation systems generally include a pulse generator and one or more leads. A stimulation lead includes a lead body of insulated material that encloses wire conductors. The distal end of the stimulation lead includes multiple electrodes that are electrically coupled to the wire conductors. The proximal end of the lead body includes multiple terminals, which are also electrically coupled to the wire conductors that are adapted to receive electrical pulses. The distal end of a respective stimulation lead is implanted within the epidural space to deliver the electrical pulses to the appropriate nerve tissue within the spinal cord that corresponds to the dermatome(s) in which the patient experiences chronic pain. The stimulation leads are then tunneled to another location within the patient's body to be electrically connected with a pulse generator or, alternatively, to an “extension.”
Spinal cord stimulation is commonly used to treat neuropathic pain and produces a subjective sensation of numbness or tingling.
A need remains for a mechanism to treat apnea episodes without undue disruption of an individual's sleep pattern.